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NCT04775953 · ClinicalTrials.gov registry record · Phase 2
DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT04775953 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 200 participants.
The verdict
NCT04775953, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
This is a Phase 2b clinical study, multicenter, randomized, open-label, assessor-blinded, superiority study. The study will compare dalbavancin to standard of care antibiotic therapy for the completion of therapy in patients with complicated bacteremia or right-sided native valve Infective Endocarditis (IE) caused by S. aureus who have cleared their baseline bacteremia. Approximately 200 subjects will be randomized 1:1 to receive either dalbavancin or a standard of care antibiotic regimen that is based upon the identification and antibiotic susceptibility pattern of the baseline organism. Subjects randomized to the dalbavancin treatment group will receive 2 doses of dalbavancin intravenously (IV) 1 week apart (1500 mg on Day 1 and Day 8 after randomization, with renal dose adjustment if appropriate). Subjects randomized to the standard of care antibiotic therapy treatment group will receive an antibiotic regimen considered to be standard of care based on the methicillin susceptibility pattern of the pathogen isolated at baseline for a duration of 4 to 6 weeks and up to 8 weeks for patients with vertebral osteomyelitis/discitis. The primary objective is to compare the Desirability of Outcome Ranking (DOOR) at Day 70 of dalbavancin to that of standard of care antibiotic therapy used to consolidate therapy for the treatment of subjects with complicated S. aureus bacteremia in the intent-to-treat population (ITT).
Interventions
- DRUG Cefazolin
- DRUG Dalbavancin
- DRUG Daptomycin
- DRUG Nafcillin
- DRUG Oxacillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04775953
The ClinicalTrials.gov registry entry for NCT04775953 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cefazolin is the first listed.
NCT04775953 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04775953 about?
NCT04775953 is a clinical study titled "DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia". This is a Phase 2b clinical study, multicenter, randomized, open-label, assessor-blinded, superiority study. The study will compare dalbavancin to standard of care antibiotic therapy for the completion of therapy in patients with complicated bacteremia or right-sided native valve Infective Endocardi...
What is the current status of trial NCT04775953?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2021-04-22. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT04775953?
The interventions under investigation include: Cefazolin (DRUG), Dalbavancin (DRUG), Daptomycin (DRUG), Nafcillin (DRUG), Oxacillin (DRUG).
Who is sponsoring clinical trial NCT04775953?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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